# K231489: Sturdy Autoclave Super Microm

- Pathway: 510(k) (Special)
- Applicant: Sturdy Industrial Co., Ltd.
- Decided: Jun 21, 2023 after 29 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936181 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181993: STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R), Sturdy Industrial Co., Ltd. (2019) Summary page 5.

## Indications for use
The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact. Cycle parameters are as follows:

Source page: https://510kreport.com/device/K231489
Methodology: https://510kreport.com/methodology